Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36

FDA recall notice · announced January 15, 2020 · Asclemed Usa Inc. Dba Enovachem Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36

Reason for recall

Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.

Notes

Distribution: Product was distributed to 6 physician's offices within the state of California.
Lot/code information: Lot Code/Exp. Date: 11061901, 04011903, 04221904, 04241904, 06031902, 07301905, 09061903, EXP 12/31/2020
Quantity: 8.52 gm
Status: Terminated
Products in this recall event:
- Estriol, USP, (Micronized), 0.12 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-37 (D-0651-2020)
- Estriol, USP, (Micronized), 0.24 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-38 (D-0652-2020)
- Estriol, USP, (Micronized), 0.06 g, Distributed by Enovachem Pharmaceuticals, Torrance CA; NCD #76420-049-36 (D-0650-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.